Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury

This study is ongoing, but not recruiting participants.
Case Western Reserve University
VA Office of Research and Development
FDA Office of Orphan Products Development
Information provided by (Responsible Party):
Kevin Kilgore, MetroHealth Medical Center Identifier:
First received: December 20, 2007
Last updated: April 14, 2015
Last verified: April 2015
The purpose of this study is to evaluate the effectiveness of an implanted stimulator and sensor for providing hand and arm function for individuals with cervical level spinal cord injury.

Condition Intervention
Spinal Cord Injury
Device: IST-12

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury

Resource links provided by NLM:

Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • Grasp-Release Test [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Activities of Daily Living Test [ Time Frame: Three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Subject lifetime ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: April 1989
Estimated Study Completion Date: January 2019
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Individuals implanted with stimulator/sensor device.
Device: IST-12
Implanted stimulator and sensor device, with twelve implanted stimulating electrodes and two myoelectric signal recording electrodes.

Detailed Description:

The design of this study is to determine the efficacy of improving upper extremity function in tetraplegic subjects after receiving an implantable device for neuromuscular control. Evaluations will be made so as to document changes in performance of manipulative tasks when using the stimulation system.

Subjects who consent to participate in this project will have an implantable stimulator surgically placed in the upper extremity for control of the upper extremity. A series of tests will be performed before implantation, and repeated at intervals after implantation to assess changes in each subject's performance.

This study is a non-randomized feasibility study with concurrent (neuroprosthesis on and off) and longitudinal (pre- and post-implantation/training) self-controls.

Subjects participating in the study can expect to be actively involved in the study for two years after implantation and followed for life thereafter. The screening procedures take up to two days, depending on the specific evaluations necessary to determine candidacy. Pre-surgical exercise is conducted for at least two weeks. The implantation surgery itself lasts one day, with three to seven days of post-surgical hospitalization. Following an eight-week exercise program and a twelve-week training program, subjects are discharged from the active rehabilitation phase. They are followed quarterly for one year, and then annually thereafter.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • C5-C8 spinal cord injury
  • Minimum of one-year post injury with no additional function prior to implantation surgery
  • Male or female
  • 18-60 years of age
  • intact vision
  • pharmacologically controlled spasticity, when applicable
  • Functional in wheelchair with adequate trunk support to allow bimanual manipulation
  • Positive attitude and motivation with supportive home environment
  • Willingness to return to laboratory for periodic evaluation and testing
  • Free of contractures known to diminish performance of the system (e.g., supination contracture of the wrist).
  • Integrity of the lower motor neuron (peripheral nerve) to the muscles to be activated
  • Adequate range of motion of joints of the shoulder, wrist, and hand (upper extremity).
  • If an acute infection is present, the subject will not be considered for surgery until it clears.

Exclusion Criteria:

  • Prior history of a major chronic systemic infection or other illness that would increase the risk of surgery.
  • Contraindications include immunologic diseases, cardiac arrhythmias, undiagnosed or high-risk breast masses, dermatologic conditions, and any major system failure.
  • Acute infection currently present that has not cleared.
  • Hypersensitivity that inhibits their ability to sustain pressure over their digits.
  • Blind
  • Uncontrolled disorders, i.e., seizures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00583804

United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Case Western Reserve University
VA Office of Research and Development
FDA Office of Orphan Products Development
Principal Investigator: Kevin L Kilgore, Ph.D. MetroHealth Medical Center
  More Information

Additional Information:
Responsible Party: Kevin Kilgore, Program Manager, MetroHealth Medical Center Identifier: NCT00583804     History of Changes
Other Study ID Numbers: IST12-PHP-2004, VA Merit Review A3707R
Study First Received: December 20, 2007
Last Updated: April 14, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by MetroHealth Medical Center:
Spinal Cord Injury
Functional Electrical Stimulation

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries processed this record on November 27, 2015